Tafasitamab Expert Event Incyte and MorphoSys Joint Conference Call
1 September 29, 2020 MorphoSys/Incyte Joint Conference Call Agenda
Dr. Malte Peters, Chief R&D Officer (MOR) Welcome and introduction
Dr. Gilles Salles r/r DLBCL and front-line DLBCL landscape
Q&A Session
Dr. Roland Wandeler, Chief Operating Officer (MOR) Monjuvi launch update
Dr. Barry Flannelly, GM North America (INCY) Monjuvi market access and U.S. opportunity in r/r DLBCL
Dr. Malte Peters, Chief R&D Officer (MOR) Tafasitamab backbone strategy and DLBCL program updates
Dr. Steven Stein, Chief Medical Officer (INCY) Global development in DLBCL and beyond
Dr. Jean-Paul Kress, Chief Executive Officer (MOR) Summary
Q&A Session
2 Forward-Looking Statements
Except for the historical information set forth herein, the matters set forth in this presentation contain predictions, estimates and other forward-looking statements, including without limitation statements regarding: expectations with respect to the commercialization of Monjuvi, including market uptake, distribution, reimbursement, the potential patient pools, and guidance with respect to peak potential revenue and market penetration; expectations with respect to the potential for Monjuvi to transform the treatment of patients with r/r DLBCL; expectations with respect to the potential for tafasitamab to treat indications beyond the currently approved indication; plans and expectations regarding the global development plan for tafasitamab, including with respect to clinical trials in additional indications and in combination with other therapies and potential therapies, such as parsaclisib, and commencement and receipt of results from clinical trials; and expectations regarding the timing and nature of determinations by regulatory authorities, including the MAA.
These forward-looking statements are based on current expectations by Incyte and MorphoSys and are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; the effects of the COVID-19 pandemic and measures to address the pandemic on commercialization efforts and clinical trials, supply chain and other third-party providers, sales and marketing efforts, and business, development and discovery operations; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development due to safety, efficacy or other reasons; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; determinations made by the FDA, MAA and other regulatory agencies outside of the United States; the acceptance of Monjuvi in the marketplace; market competition; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for Monjuvi; the continued ability to successfully commercialize and build commercial infrastructure for Monjuvi; and other risks detailed from time to time in the reports filed by Incyte and MorphoSys with the U.S. Securities and Exchange Commission, including Incyte’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and MorphoSys’ Annual Report on Form 20-F for the year ended December 31, 2019. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements These forward-looking statements speak only as of the date of publication of this document and Incyte and MorphoSys expressly disclaim any obligation to update any such forward- looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.
3 Dr. Gilles Salles, M.D.
4 Diffuse large B-cell lymphoma (DLBCL) current landscape and challenges
Professor Gilles Salles* Memorial Sloan Kettering Cancer Center New York
*Dr. Gilles Salles is acting in his personal capacity Disclosures
Gilles Salles has received financial compensations for participating to advisory boards, consulting or educational events from:
Abbvie, Allogene, Beigene, Autolus, BMS/Celgene, Debiopharm, Genmab, Kite/Gilead, Epizyme, Janssen, Karyopharm, Morphosys, Novartis, Roche, Velosbio
29.09.2020 Professor Gilles Salles 6 Epidemiology of non-Hodgkin lymphoma (NHL) Incidence of B-cell lymphoma in the US # 70 000 new patients each year
B-cell NHL
Diffuse large B-cell lymphoma Follicular lymphoma MALT lymphoma Mantle cell lymphoma CLL/SLL lymphoma Primary mediastinal lymphoma High grade NOS lymphoma Burkitt lymphoma Splenic marginal zone lymphoma Nodal marginal zone lymphoma Lymphoplasmacytic lymphoma
Teras LR, CA CANCER J CLIN 2016
29.09.2020 Professor Gilles Salles 7 Epidemiology of diffuse large B-Cell lymphoma (DLBCL)
• Most frequent Non Hodgkin Lymphoma (~30-35% of cases)
• Spontaneous aggressive evolution
• Various histological forms, and frequent coexistence or evolution from an indolent component
• Sex ratio male/female is 2
29.09.2020 Professor Gilles Salles 8 An increased frequency at older age Median age at diagnosis # 65 - 70 years
Teras LR, CA CANCER J CLIN 2016
29.09.2020 Professor Gilles Salles 9 Incidence stable over the last 2 decades
Teras LR, CA CANCER J CLIN 2016
29.09.2020 Professor Gilles Salles 10 DLBCL morphology
CD19
Modiefied from Le Gouill et al., Haematologica 2007
29.09.2020 Professor Gilles Salles 11 DLBCL molecular biology
The Molecular Diagnosis of Large B Cell Lymphoma v2.0
Rosenwald et al., N Engl J Med. 2002; Wright GW, et al. Cancer Cell. 2020
29.09.2020 Professor Gilles Salles 12 Before the monoclonal antibodies… Overall Survival
Fisher et al, N Engl J Med 1993; 328:1002-1006
29.09.2020 Professor Gilles Salles 13 Adding a monoclonal anti-CD20 antibody to CHOP Patients 60-80 yrs: LNH 98.5 GELA study
Coiffier et al. NEJM 2002
29.09.2020 Professor Gilles Salles 14 R-CHOP versus CHOP BCCA real life cohort
Sehn LH et al., J Clin Oncol. 2005
29.09.2020 Professor Gilles Salles 15 DLBCL survival at 3, 5 and 10 years in the United States recent SEER data # 64% OS at 5 years
Teras LR, CA CANCER J CLIN 2016
29.09.2020 Professor Gilles Salles 16 DLBCL: recent attempts to improve R-CHOP
Add a new targeted agent: R-CHOP-21 bortezomib1, ibrutinib2 and lenalidomide3
Consolidate with maintenance rituximab4, lenalidomide5, enzastaurin6, everolimus7
Replace one component bortezomib8, obinutuzumab9
1: Leonard, 2019 ; Davies, 2019 ; 2: Younes, 2019 ; 3: Vittolo, 2019 ; 4: Habberman, 2006; Jaeger, 2015 ; 5 :Thieblemont 2017 ; 6: Crump 2018 ; 7: Witzig 208 ; 8: Offner 205 ; 9 : Vittolo, 2017
29.09.2020 Professor Gilles Salles 17 DLBCL: recent attempts to improve R-CHOP
Add a new targeted agent: R-CHOP-21 bortezomib1, ibrutinib2 and lenalidomide3
Consolidate with maintenance rituximab4, lenalidomide5, enzastaurin6, everolimus7
Replace one component bortezomib8, obinutuzumab9
1: Leonard, 2019 ; Davies, 2019 ; 2: Younes, 2019 ; 3: Vittolo, 2019 ; 4: Habberman, 2006; Jaeger, 2015 ; 5 :Thieblemont 2017 ; 6: Crump 2018 ; 7: Witzig 208 ; 8: Offner 205 ; 9 : Vittolo, 2017
29.09.2020 Professor Gilles Salles 18 High incidence of r/r DLBCL within the U.S.
~30,000 ~60% of all 1L Patients treated in 1L patients cured by R- CHOP ~10-15% refractory ~20-30% relapsed
r/r DLBCL ~30% of all DLBCL patients ~50%
~50%
ASCT eligible ASCT ineligible
~50%
Transplant ~50% No transplant 30% - 40%
Cure
Relapse 15-20% of all ASCT eligible 60% - 70% patients are cured by transplant
DRG Epidemiology data for DLBCL (de novo + transformed from FL or CLL); Kantar Market Research (TPP testing 2018), Friedberg et al., 2011
29.09.2020 Professor Gilles Salles 19 Event-Free Survival after ASCT
Gisselbrecht C, Schmitz N, Mounier N, Singh Gill D, Linch DC, Trneny M et al. Rituximab maintenance therapy after autologous stem-cell transplantation in patients with relapsed CD20(+) diffuse large B-cell lymphoma: final analysis of the collaborative trial in relapsed aggressive lymphoma. J Clin Oncol 2012; 30: 4462–4469.
29.09.2020 Professor Gilles Salles 20 R/R DLBCL: Standard of Care before approval of tafasitamab
Transplant eligible Transplant ineligible
≥ 2 line 2nd line ≥ 3 line
DHAP +/- R Pola-BR DHAX +/- R CAR-T approved
GDP… +/- R Selinexor
ICE… +/- R GemOx +/- R recommended … Bendamustine +/- R
NCCN Guidelines, Version 4.2020
29.09.2020 Professor Gilles Salles 21 Results of R-GemOx in r/r DLBCL
According to time from last treatment Median n PFS months
Time of last treatment / C1<1 year 22 3
Time of last treatment / C1≥1 year 26 10
According to prior Rituximab Prior No prior P rituximab: rituximab: ORR 32% 71% 0.01 PFS 4 months 11 months 0.02 OS 8 months 27 months 0.02
Mounier et al, 2012
29.09.2020 Professor Gilles Salles 22 Results of R-GemOx in r/r DLBCL
According to time from last treatment Median n PFS months
Time of last treatment / C1<1 year 22 3
Time of last treatment / C1≥1 year 26 10
According to prior Rituximab Prior No prior P rituximab: rituximab: ORR 32% 71% 0.01 PFS 4 months 11 months 0.02 OS 8 months 27 months 0.02
Mounier et al, 2012
29.09.2020 Professor Gilles Salles 23 Polatuzumab vedotin added to bendamustine / rituximab Response rates
Response at EOT (IRC)1*
100 90 80 70 60 50 45 40 Patients (%) Patients 40 30 18 18 20 10 BR 0 Pola + BR OR CR
Seven patients have ongoing response durations of ≥20 months at data cut-off
Data cut-off: 1. 30 April 2018, 2. May 2017 *Primary endpoint; PET-CR is assessed by modified Lugano criteria BOR, best overall response; BR, bendamustine and rituximab; CR, complete response; EOT, end of treatment; 1. Sehn L, et al. Abstract #1683, ASH 2018 | 2. Sehn L, et al. Abstract #7507. ASCO 2018 INV, investigator; IRC, independent review committee; OR, objective response; pola, polatuzumab vedotin
29.09.2020 Professor Gilles Salles 24 Polatuzumab vedotin added to bendamustine / rituximab Duration of response
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761121Orig1s000TOC.cfm
29.09.2020 Professor Gilles Salles 25 Polatuzumab vedotin added to bendamustine / rituximab Progression Free Survival (IRC)
. Few patients with durable responses . Toxicity: hematological, infectious, neurological
Sehn, JCO 2019
29.09.2020 Professor Gilles Salles 26 Axicabtagene Ciloleucel PFS and OS by Baseline ECOG and LDH
Loretta J. Nastoupil et al, JCO 2020
29.09.2020 Professor Gilles Salles 27 CAR-T cells
FAVOR ISSUES • Attractive innovation • Logistic complexity • High response rates • Not readily available ORR 50 – 80% Patients selection • High CR rates • Specific Gr 3-4 adverse events 40 – 55% • Costs, availability • Durable responses 70 – 80% of CR patients at 2 y
29.09.2020 Professor Gilles Salles 28 R/R DLBCL: Standard of Care after approval of tafasitamab
Transplant eligible Transplant ineligible
≥ 2 line 2nd line ≥ 3 line
DHAP +/- R Tafasitamab + LEN Pola-BR DHAX +/- R CAR-T approved
GDP… +/- R Selinexor
ICE… +/- R GemOx +/- R recommended … Bendamustine +/- R
NCCN Guidelines, Version 4.2020
29.09.2020 Professor Gilles Salles 29 CD19 and CD20 expression during B-cell development
https://www.researchgate.net/figure/Summary-of-CD19-and-CD20-expression-during-B-cell-development-CD19-expression-is_fig1_323911459
29.09.2020 Professor Gilles Salles 30 Tafasitamab a humanized and engineered anti-CD19 Ab Previously known as XmAb5574, then MOR208
29.09.2020 Professor Gilles Salles 31 Long duration of response with tafasitamab as monotherapy
Phase II Single agent study
ORR DLBCL : 26% (6% CR) FL: 29% (9% CR)
Jurczak et al, Ann Oncol 2018
29.09.2020 Professor Gilles Salles 32 Mode of actions provide the rationale for tafasitamab + lenalidomide combination
Tafasitamab MoA . Antibody Dependent Cellular Cytotoxicity via NK cells (ADCC) . Antibody Dependent Cellular Phagocytosis (ADCP) . Direct cytotoxicity
Lenalidomide MoA . Direct cytotoxicity . Increase NK cell numbers (ADCC) . Activate NK cells
Increased anti-tumor effects
29.09.2020 Professor Gilles Salles 33 L-MIND: Study design Phase 2, single-arm, open-label, multicenter study (NCT02399085)
. Sample size suitable to detect ≥15% absolute increase in ORR for Tafasitamab/LEN combination vs. LEN monotherapy at 85% power, 2-sided alpha of 5% . Mature Data: Primary Endpoint Analysis with data cut-off 30 Nov 2018; minimum Follow-Up 12 months, median Follow-Up 17.3 months
29.09.2020 Professor Gilles Salles 34 Patient characteristics
Characteristic Specification n=81 (%) Age [years]* median (range) 72 (41-86) 0-2 40 (49) Risk (IPI)* 3-5 41 (51) I-II 20 (25) Ann Arbor Stage* III-IV 61 (75) Yes 45 (56) Elevated LDH* No 36 (44) 1 40 (49) Prior Lines (median=2) * 2 35 (43) 3-4 6 (7) Yes 36 (44) Refractory to last prior therapy* No 45 (56)
Primary Refractory Yes 15 (18)
Prior SCT Yes 9 (11)
GCB 37 (46) Cell of Origin Non-GCB 20 (25) (Centrally assessed - Hans algorithm) Unknown 24 (30)
*at study entry | IPI, international prognostic index; LDH, lactate dehydrogenase; SCT, stem cell transplant Salles et al, Lancet Oncol. 2020
29.09.2020 Professor Gilles Salles 35 Primary endpoint: Overall Response Rate (ORR) by IRC
ORR 60.0% (95% CI: 48.4%–70.8%) CR-rate 42.5% • 82% of CRs PET-confirmed • 18% of CRs based on CT only
N=80: full analysis set patients receiving at least one dose of tafasitamab and LEN NE due to missing post-baseline tumor assessment
CI, confidence interval; CR, complete response; CT, computed tomography; IRC, independent review committee; LEN, Lenalidomide; NE, not evaluable; ORR, overall response rate; PET, positron emission tomography; PR, partial response; PD, progressive disease; SD, stable disease. Salles et al, Lancet Oncol. 2020
29.09.2020 Professor Gilles Salles 36 Consistent ORR in subgroups, including refractory patients
Characteristic N Best ORR, % (95% CI) Best ORR, % Age group ≤70 yr 35 62.9 >70 yr 45 57.8 Gender Female 37 54.1 Male 43 65.1 IPI score Intermediate-High and High risk 40 50.0 Low and Low-Intermediate risk 40 70.0 Rituximab refractoriness Yes 33 57.6 No 46 60.9 Prior treatment lines 1 40 70.0 ≥2 40 50.0 Primary refractoriness Yes 15 60.0 No 65 60.0 Prior ASCT Yes 9 77.8 No 71 57.7 Refractoriness to last Yes 35 60.0 prior therapy No 45 60.0 0 20 40 60 80 100 Best ORR (95% CI) ORR=overall response rate; ASCT=autologous stem cell transplantation; IPI=international prognostic index
Salles et al, Lancet Oncol. 2020
29.09.2020 Professor Gilles Salles 37 Duration of Response (IRC)
Median DoR 21.7 mo (95% CI: 21.7–NR) Median DoR for CR patients: NR (95% CI: 21.7–NR) Median DoR for PR patients: 4.4 mo (95% CI: 2.0–9.1)
CI, confidence interval; CR, complete response; DoR, duration of response; IRC, independent review committee; NR, not reached; PR, partial response. Salles et al, Lancet Oncol. 2020
29.09.2020 Professor Gilles Salles 38 12-months DOR by baseline characteristics
Two patients had DHL/THL after central FISH review: one with DHL achieved PR only; another patient with THL (was also primary refractory subgroup) achieved CR and remains in remission after >30 months.
Salles et al, Lancet Oncol. 2020 (supplemental data)
29.09.2020 Professor Gilles Salles 39 L-MIND – Outcome in 2nd line subpopulation
N=40 ORR 70.0 %
CR rate 52.5%
Median PFS 23.5 mo
12 months OS rate* 86.9 %
*Kaplan Meier Analysis
Duell et al, ASH 2019
29.09.2020 Professor Gilles Salles 40 L-MIND – Long-term follow-up (≥24 months) DOR (IRC)
1.0 0.9 0.8 0.7 0.6 0.5
0.4 remission 0.3 Median DoR:
0.2 PR: 5.6 months (95% CI: 2.2–34.6) Proportion of patients in in patients of Proportion 0.1 CR: NR (95% CI: 26.1–NR) PR/CR: 34.6 months (95% CI: 26.1–34.6) 0.0 0 1 3 6 12 18 24 30
Number of patients at risk Time (months) PR 14 13 10 5 4 2 1 1 CR 33 32 30 29 23 22 11 8 PR/CR 47 45 40 34 27 24 12 9 Censored
Salles et al, EHA 2020
29.09.2020 Professor Gilles Salles 41 L-MIND – Long-term follow-up (≥24 months) PFS (IRC)
1.0
0.9 - 0.8 0.7 0.6
0.5 of progression of 0.4
free survival free 0.3
0.2 Probablity 0.1 Median PFS: 16.2 months (95% CI: 6.3-NR) 0.0 0 1 3 6 12 18 24 30 Number of patients at risk Time (months) Tafasitamab 80 72 56 42 31 28 16 12 + LEN Censored
Salles et al, EHA 2020
29.09.2020 Professor Gilles Salles 42 L-MIND – Long-term follow-up (≥24 months) OS
1.0 0.9 0.8 0.7 0.6
of overall of 0.5
survival survival 0.4 0.3
Probablity 0.2 Median OS: 31.6 months (95% CI: 18.3-NR) 0.1
0 1 3 6 12 18 24 36 Number of patients at risk Time (months) Tafasitamab 80 77 69 64 54 45 37 13 + LEN Censored
Salles et al, EHA 2020
29.09.2020 Professor Gilles Salles 43 Safety by treatment phase
Tafasitamab + LEN combination (up to 12 cycles) Tafasitamab monotherapy (cycle 13 onwards or after LEN n=80, median exposure 6.5 months discontinuation) n=37, median exposure 8.7 months
Incidence and severity of TEAEs is lower during the tafasitamab monotherapy phase 10 patients (12%) discontinued tafasitamab + LEN due to AE
AE collection period included 30 days after end of treatment. | LEN, Lenalidomide.
Salles et al, Lancet Oncol 2020
29.09.2020 Professor Gilles Salles 44 L-MIND: Conclusions
. Tafasitamab + LEN showed high ORR and CR rate with durable responses
. High activity consistently observed in patient subgroups with limited treatment options and poor prognosis
. Overall survival data are favourable
. The combination therapy was well tolerated . Safety profile largely driven by lenalidomide . Safety profile of tafasitamab is as expected for a B-cell depleting mAb
29.09.2020 Professor Gilles Salles 45 New agents in development in B-cell NHL
. Naked anti-CD20, anti-CD19 mAbs . Antibody drug conjugates . Bispecific antibodies
. Immune checkpoint blockers (new one’s ?) . IMIDs (new ones or in combination) . R2 . L-MIND regimen
. Cell signaling (BCR & others) . Intracellular trafficking (selinexor, …) . Apoptosis (venetoclax, anti-MCL1) . Epigenetic (tazemetostat)
29.09.2020 Professor Gilles Salles 46 Novel agents in development for DLBCL
Overall Complete Class Target Agent Phase response response Reference rate (%) rate (%) Monoclonal antibody CD19 tafasitamab + lenalidomide 2 60 43 Salles et al
CD19 loncastuximab tesirine 1 59 41 Kahl et al
Antibody drug polatuzumab vedotin 1 52 13 Palanca-Wessels et al conjugates CD79b polatuzumab vedotin + BR 45 40 2 randomized Sehn et al versus BR 17.5 17.5 CD19/CD3 blinatumomab 2 43 19 Viardot et al Bispecific mosunetuzumab 1/1b 35 19 Schuster et al antibodies CD20/CD3 glofitamab 1/1b 38 31 Dickinson et al
Other target BCL2 venetoclax 1 18 12 Davids et al inhibitors XPO1 selinexor 2b 28 12 Kalakonda et al
Checkpoint PD-1 nivolumab 2 ≤ 10 ≤ 3 Ansell et al inhibitors CD47 magrolimab 1b 40 33 Advani et al
Salles et al., Lancet Oncol. 2020; Kahl et al., Clin Cancer Res. 2019; Palanca-Wessels et al., Lancet Oncol. 2015; Sehn et al., JCO 2020; Viardot et al., Blood 2016; Schuster el al., ASH 2019; Dickinson et al., EHA 2020; Davids et al., JCO 2017; Kalakonda et al., Lancet Haematol. 2020; Ansell et al., JCO 2019; Advani et al., N Engl J Med., 2018
29.09.2020 Professor Gilles Salles 47 Unmet need in frontline DLBCL Prognosis significantly declines with IPI score of 3-5
3-yr Progression- 3-yr Overall Incidence2 Progression-free survival by IPI2 free survival (PFS)1 survival (OS)1 Low risk – IPI score of 0 or 1 87% 91% 28%
Low-intermediate risk – IPI score of 2 75% 81% 27%
High-intermediate risk – IPI score of 3 59% 65% 21%
High risk – IPI score of 4 or 5 56% 59% 24%
1: Ziepert M, et al.; J Clin Oncol. 2010; 2: Sehn eta al., Blood, 2007.
29.09.2020 Professor Gilles Salles 48 Clinical trials in 1L DLBCL - Points to consider ROBUST Trial – Positive trend in high risk subgroup PhIII R2‐CHOP vs R‐CHOP in previously untreated ABC‐type DLBCL
PFS Hazard Ratio Overall Population 0.85 (95% CI, 0.63‐1.14) Disease stage III/IV 0.81 (95% CI, 0.60‐1.10) IPI score ≥ 3 0.74 (95% CI, 0.53‐1.05)
Vitolo et al 2019
29.09.2020 Professor Gilles Salles 49 Rationale for combining tafasitamab and lenalidomide and R-CHOP in 1L DLBCL
• Synergistic MoA of tafastimab + LEN • Strong data of tafastimab + LEN in R/R DLBCL • Expression pattern on biopsies of newly diagnosed B-cell lymphomas supports targeting CD20 and CD19* • CD19 expression more homogenous compared to CD20 • CD19 expression preserved in small CD20-negative tumor subsets • High risk patients (IPI 3-5) with unmet medical need and positive trend in previous 1L DLBCL PhIII trial
*Horna et al EHA, 2020
29.09.2020 Professor Gilles Salles 50 First-MIND: Purpose, objectives and endpoints International, open-label, prospective, randomized phase 1b study in 1L DLBCL
First MIND to confirm the safety and preliminary efficacy of tafasitamab in addition to R-CHOP (Arm A) or tafasitamab plus lenalidomide in addition to R-CHOP (Arm B) in patients with newly diagnosed DLBCL (NCT04134936)
Arm A: ~60 pts previously untreated newly Tafasitamab: Cycle 1-6, Day 1, 8 ,15 diagnosed DLBCL + R-CHOP: 6 cycles every 21 days Age ≥ 18 DLBCL NOS R Follow-up of 18 Arm B: IPI 2-5 1:1 months Tafasitamab: Cycle 1-6, D1, 8 ,15 ECOG 0-2 + Appropriate Lenalidomide: Cycle 1-6, D 1-10 candidate for (25mg/d)
R-CHOP + End of Study End Study (EOS)Visit of R-CHOP: 6 cycles every 21 days Visit Treatment(EOT) of End
Primary endpoint Secondary endpoints Exploratory endpoints • Safety (TEAEs) • Long-term safety • ctDNA analysis • Efficacy: PET-CR, ORR, EFS, • ORR/PFS by: COO; NK cell count in peripheral blood / TTNT, PFS, and OS tumor tissue; Quantitative CD19 and CD20 expression • Pharmacokinetics and on tumor tissue immunogenicity of Tafasitamab • Other biomarkers
29.09.2020 Professor Gilles Salles 51 Q&A Session
52 Dr. Roland Wandeler, Ph.D.
Chief Operating Officer, MorphoSys
53 First FDA approved 2nd line therapy in r/r DLBCL Opportunity to transform standard of care in r/r DLBCL
Accelerated . FDA-accelerated approval of MONJUVI® (tafasitamab-cxix)* FDA approval in combination with lenalidomide on 31 July 2020
. First FDA-approved 2nd line therapy in r/r DLBCL, First 2nd line for patients not eligible for autologous stem cell transplant (ASCT)
Potential . Addressing significant unmet medical need to transform . Potential to transform the treatment of patients with r/r DLBCL standard of care
. Delivered on speed to market Building . Able to engage customers in COVID context momentum . Encouraged by early adoption and uptake
*MONJUVI, in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem 54 cell transplant (ASCT). Addressing unmet medical need Key messages
For r/r DLBCL patients in 2L+, not eligible for Indication autologous stem cell transplant, MONJUVI®, in combination with lenalidomide, is MONJUVI® + lenalidomide … indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma Efficacy (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not … is the first and only 2L+ therapy resulting in eligible for autologous stem cell transplant (ASCT). complete and durable responses
Safety & Tolerability Key efficacy data1 … has a combined safety & tolerability profile that supports treatment to progression, allowing for long- . Best overall response rate 55% term disease control . Complete response rate 37% Accessibility . Median duration of response 21.7 months … is an efficient anti-CD19 therapy, both community & academic-accessible, easy to administer, and not requiring hospitalization or continuous monitoring
55 1. USPI https://www.monjuvi.com/pi/monjuvi-pi.pdf Speed to market: First patient dosed 10 days after approval Key milestones, business days after FDA approval
Fri, 31 Jul Week 1 Week 2 Week 3
FDA Approved Listing Regulatory 31 July 3 days
Distributors Supply & US Supply Available Stocked Distribution 3 days 4 days Patient Program First Support Launched Inquiry Support 1 day 2 days First Account First Account First Patient Customer Order Formulary Dosed 5 days 8 days 10 days Payers First Coverage CMS Coding Payer Notified Confirmed Submission 1 day 10 days 14 days Guideline NCCN Guidelines submission Guidelines 2A 1 day 9 days
56 Reaching customers in COVID context Driving engagement with physicians ahead of expectations
Individual engagement Peer-to-peer engagement Closed loop digital engagement
>30,000 >120 Emails to key customers Speaker programs completed or planned over next 3 months HCP and patient Social websites connections >4,400 Virtual education platform Calls
>1,800 Medical engagements Digital Email advertising campaigns
57 Attained clear leadership in share of voice Translating share of voice into engagement
Evolution of share of voice Share of voice (As of 9/18/20)
MONJUVI® compared to: 70%
60% Kymriah 50% Polivy
40% Xpovio Yescarta 30%
20% Share Share ofVoice
10%
0% MONJUVI 6/26 7/3 7/10 7/17 7/24 7/31 8/7 8/14 8/21 8/28 9/4 9/11 9/18 n=42 54 74 82 87 86 85 98 109 113 110 104 100 62% dr=37 45 58 63 68 71 70 75 79 79 81 81 81 Monjuvi
MONJUVI® compared to: Kymriah, Polivy, Xpovio, Yescarta
Source: IQVIA BrandImpact Weekly Tracking; week ending September 18, 2020 58 Encouraged by early adoption and uptake by key centers Select metrics as of late September
>6,200 Personal meetings with HCPs as customers want to engage with us despite COVID Thereof • ~50% academic ~50% community >100 Key accounts already ordered • ~50% of NCCN institutions many top accounts using exception processes for speed ~50% of overall demand from top 100 key accounts >57% Formulary approvals in top 30 accounts on track to gain positive formulary decisions in the remaining Key Accounts
>43% EMR / order sets added in top 30 accounts supporting pull-through to enable broader uptake across networks
59 Early physician feedback suggests good adoption Select quotes from advisory boards and personal engagements
“What was most impressive was the Main HCP feedback durability of those responses. Well over “The duration of 50% of patients were still in remission response is particularly . Impressive efficacy, at 18 months.” impressive.” especially duration of response
. Well tolerated “If the goal is to keep the patient alive with minimum toxicity, I think that’s a good drug to use . Easy to use in both community and academic settings “A natural fit [for “Accessibility is a huge community-based benefit to patients, physicians].” especially now during a healthcare crisis.”
“Definitely fit immediately into my relapse/refractory paradigm especially for those that will not be a candidate for CAR-T”
60 Dr. Barry Flannelly, Pharm.D.
General Manager, North America, Incyte
61 Ensuring strong payer access and providing patient support for MONJUVI®
No notable access restrictions My MISSION Support; services include: No distribution delays for MONJUVI . Education and support with coverage, coding Product availability within days of approval and reimbursement and financial assistance for eligible patients
Reimbursement progress Broad reimbursement achieved; where prior authorization req‘d, policies in line with expectations . Reimbursed under Medicare Part B . Covered under multiple commercial plans Expect vast majority of lives covered within first year of launch
Rapid inclusion of MONJUVI in NCCN guidelines1 Increases awareness of MONJUVI with HCPs Drives formulary discussions
1. Category 2A of NCCN guidelines: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate. NCCN: National Comprehensive Cancer Network (NCCN) guidelines 62 High incidence of r/r DLBCL within the U.S. Potential for MONJUVI® to transform the standard of care in 2L+ DLBCL
FDA approved therapies in DLBCL ~30,000 R-CHOP patients treated in 1L 1st Line
~60% of all 1L patients cured R-CHOP
2nd Line ~15-20% of ASCT eligible patients cured ~6,000 ASCT eligible ~5,000
~5,000 3rd Line+ axicabtagene ciloleucel ~10,000 patients tisagenlecleucel eligible for MONJUVI polatuzumab selinexor
63 Source: DRG Epidemiology data for DLBCL (de novo + transformed from FL or CLL); Incyte and MorphoSys analyses r/r DLBCL represents a substantial opportunity in the U.S. Potential for extended duration of therapy in complete responders
# of eligible ~10,000 new eligible patients each year; ~5,000 2L and ~5,000 3L+ patients
New Share of NEW patients: patients One of the standards of care in r/r DLBCL
Peak sales potential for MONJUVI® Ongoing Growing proportion of ONGOING patients: in r/r DLBCL in the U.S. patients Treatment to progression and long duration of response US$ 500 – 750 million
US$ 6,000 (WAC) per dose, on average Price Year 1: 33 doses; Year 2+: 26 doses
64 Dr. Malte Peters, M.D.
Chief R&D Officer, MorphoSys
65 Ambition to improve cure rates in DLBCL
Establish MONJUVI® (tafasitamab)-LEN as Standard of Care in r/r DLBCL 1 . Preferred option for appropriate 2L patients, based on ORR and duration of response
Further develop tafasitamab as backbone in DLBCL tafasitamab . The combination partner of choice along the entire patient journey – to become the 2 1st line 2nd line 3rd line backbone . Supported by favorable benefit-risk profile, excellent combinability treatment to and ease of use improve cure rates in Expand development into other heme malignancies hematological 3 . Development in other B-cell malignancies based on broadly expressed cancers CD19 antigen: FL, CLL, MZL, ALL, MCL
Increase value through lifecycle management 4 . Increasing the value via purposeful developments in: . Additional regions, e.g. China, Japan . More convenient formulations & dosing / regimen, e.g. SC
Len: lenalidomide, FL: follicular lymphoma, MZL: marginal zone lymphoma, CLL: chronic lymphocytic leukemia, ALL: acute lymphocytic leukemia, MCL: mantle cell lymphoma 66 DLBCL: Tafasitamab backbone strategy
DLBCL: 1st Line r/r DLBCL: 2nd Line r/r DLBCL: 3rd+ Line
tafasitamab + len L-MIND: tafasitamab + len tafasitamab (+len) + + R-CHOP combination partner ongoing FDA approved
Phase 1b safety study ongoing Discussions with companies developing innovative therapies, Advanced protocol discussed B-MIND: tafasitamab + ben with FDA for pivotal study e.g., Tafa/len in combination with Bi-specifics novel agents ongoing mAbs Small molecules Other established therapies
len: lenalidomide, ben: bendamustine 67 Epidemiology of diffuse large B-cell lymphoma Rationale for combining tafasitamab + LEN with R-CHOP in front-line DLBCL
Most common type of NHL in 30,000 patients newly diagnosed ~40% of patients do not respond adults worldwide in the U.S. per year to R-CHOP or relapse
. Need to improve the efficacy of R-CHOP Progression-free survival by IPI2 . High risk patients (IPI 3-5) with unmet medical need
. Strong data of tafasitamab + LEN in r/r DLBCL
. Expression pattern on biopsies of newly diagnosed B-cell lymphomas supports targeting CD20 and CD19
. CD19 expression more homogenous compared to CD20
. CD19 expression preserved in small CD20-negative tumor subsets
Sehn et al., Blood, 2007 68 Ambition to improve cure rates in DLBCL First-MIND Ph1b study – PET-CT at interim staging showing CR
Screening After 3 cycles (CR)
R-CHOP + tafasitamab + lenalidomide (75 years, stage IV, IPI 4)
THIS IS A SINGLE PATIENT RESPONSE WHICH IS PROVIDED FOR ILLUSTRATION ONLY. THE PRODUCT IS IN DEVELOPMENT IN THIS INDICATION AND THIS ILLUSTRATION DOES NOT GUARANTEE ALL PATIENTS WILL OBSERVE THE SAME EFFICACY NOR HEALTH AUTHORITIES APPROVAL. 69 Front-MIND: A pivotal phase 3 study in front-line DLBCL Study design discussed with FDA
Front-MIND (Phase 3, multicenter, randomized, double-blind, placebo-controlled trial) First-MIND Experimental arm (n=440) (Phase 1b) Key inclusion criteria 12 mg/kg tafasitamab . Arm A (n=30) 25 mg/day lenalidomide tafasitamab Previously untreated DLBCL patients + R-CHOP : PFS +R-CHOP . IPI 3-5 R . ECOG 0-2 1:1 . Arm B (n=30) endpoint . Diagnosis to tx tafasitamab interval ≤ 28 days Control arm (n=440)
lenalidomide tafasitamab placebo Primary Primary + R-CHOP lenalidomide placebo + R-CHOP
70 Frontline DLBCL – Pivotal phase 3 Post marketing requirement: As agreed upon with FDA
Expected timelines
2020 2021 2022 2023 2024 2025 2026
First-MIND Front-MIND (Phase 1b) (Phase 3)
Study start Primary BLA/MLA Potential completion filing approval
71 Tafasitamab development supported by IIT program
Combinations Patients Indications
• Chemotherapy • Pre / post CAR-T • Diffuse large B-cell lymphoma • Chemo-free regimen • Transplant eligble patients • Marginal zone lymphoma • Elderly patients: 80 y/o + • Acute lymphocytic leukemia
Broad tafasitamab development supported by comprehensive IIT program >30 proposals from academic centers ~10 IITs jointly approved by MorphoSys and Incyte First IIT to start in Q4 2020
IIT: investigator initiated trial 72 Dr. Steven Stein, M.D.
Chief Medical Officer, Incyte
73 r/r DLBCL represents a significant unmet need worldwide Development in Europe on track; MAA decision expected in H2 2021
r/r DLBCL epidemiology in Europe ~40,000 patients treated in 1L ~14,000 new patients with r/r DLBCL
each year, not eligible for ASCT ~60% of all 1L patients cured EMA approved therapies for DLBCL R-CHOP . 1L: R-CHOP . 2L: polatuzumab/RB . 3L: axicabtagene ciloleucel, ~15-20% of tisagenlecleucel, selinexor ASCT eligible patients cured ~8,300 ASCT eligible ~7,700 Key ex-US updates MAA decision expected in H2 2021 ~6,500
Ongoing development plans for: ~14,000 patients . Canada eligible for . Japan tafasitamab . China
DRG Epidemiology data; Kantar Market Research (TPP testing 2018), Friedberg et al., 2011 74 Follicular lymphoma is the second most common subtype of NHL More than 17,000 new treated cases of r/r follicular lymphoma in US, EU, Japan each year
CD20/chemotherapy and R2 are the preferred therapies in 2L PI3Kδ inhibitors are now part of 3L+ regimens
1st Line 2nd Line 3rd Line +
FL Deaths/Yr ~32,000 ~17,000 ~12,000 drug-treated drug-treated drug-treated ~4,500 patients patients patients
Epidemiology estimates based on DRG NHL report, Globocon/WHO NHL incidence estimates, SEER FL incidence and mortality estimates and American Cancer Society US incidence estimates. 75 Pivotal trial planned in r/r follicular lymphoma Global safety and efficacy trial expected to start in early 2021
EOT
Summary study design (r/r FL) tafasitamab + R2
. Phase 3, global safety/efficacy trial . Randomized, placebo-controlled n~500 . Key inclusion criteria 1:1 ̶ r/r FL patients aged ≥18 years ̶ ≥1 prior anti-CD20 therapy placebo + R2 ̶ No prior R2
Primary endpoint: PFS
R2 = lenalidomide (LEN) + rituximab; EOT = end of therapy 76 Opportunity for CD19 and PI3K delta combination Potential for increased antitumor activity with tafasitamab + parsaclisib
Rationale for anti-CD19 + PI3Kδi combination PI3Kδ in cancer: . Dysregulated PI3K activity may promote tumor cell survival in cancer1-4 . PI3K plays a key role in survival and development of B lymphocytes5 . PI3K is upregulated and a critical driver of growth and survival in B-cell malignancies5-8 CD19 plays a key role in:9 . B-cell development and differentiation . B-cell proliferation . B-cell signaling
1. Chalhoub N, Baker SJ. Annu Rev Pathol. 2009;4:127-150. 2. Fruman DA, et al. Nat Rev Drug Discov. 2014;13:140-156. 3. Brana I, Siu LL. BMC Med. 2012;10:161. 4. Martini M, et al. Front Oncol. 2013;3:108. 5. Puri K, Gold MR. Front Immunol. 2012;3:256. 6. Ortiz-Maldonado V, et al. Ther Adv Hematol. 2015;6:25-36. 7. Akinleye A, et al. J Hematol Oncol. 2013;6:88. 8. Castillo J, et al. Onco Ther Targets. 2014;7:333-342. 9. 77 Del Nagro CJ, et al. Immunol Res. 2005;31:119-131. Combination of tafasitamab + PI3Kδi demonstrated activity in CLL COSMOS PoC data warrant further study of anti-CD19 + PI3Kδi combination
COSMOS Recap Cohort A (n=11) tafasitamab + idelalisib r/r CLL patients post BTKi
Efficacy . ORR of 91% (10/11)
Safety . Grade ≥3 TEAE (n): – neutropenia (5) – anemia (3) – thrombocytopenia (3)
ClinicalTrials.gov Identifier: NCT04134936. Primary analysis for both cohorts had cut-off date of Nov 2018 (start Nov 2016). Study completion August 2022. Preliminary results reported at ASH 2018 for Cohort B and EHA 2018 for Cohort A. Primary analysis for both cohorts at ASH 2019, 78 with data cut-off October 2019. CLL = chronic lymphocytic leukemia; SLL = small lymphocytic leukemia. Tafasitamab + parsaclisib development plan in NHL Parsaclisib is a potent and highly selective next-generation PI3Kδ inhibitor
Planned combination trial with tafasitamab + parsaclisib Final protocol in preparation
Proposed study design tafasitamab + parsaclisib
. PoC study Part 1 Part 2 . Key inclusion criteria Safety assessment Expansion cohorts ̶ r/r B-cell malignancies ̶ ≥1 prior anti-CD20 therapy
End of Part 1
79 Comprehensive global clinical program Multiple opportunities to address significant unmet needs in non-Hodgkin lymphomas
Study Arms Status PoC Pivotal
L-MIND (~80 pts) + lenalidomide FDA approved in 2L+ DLBCL Primary endpoint: ORR (2-year analysis presented at EHA 2020) r/r + bendamustine DLBCL B-MIND (~450 pts) Ongoing, data expected 2022 Primary endpoint: PFS vs bendamustine + rituximab (IDMC futility passed November 2019)
+ R-CHOP Primary completion expected First-MIND (~60 pts) Safety or + lenalidomide + R-CHOP 2020
1L 1L + lenalidomide + R-CHOP
DLBCL Front-MIND (~900 pts) Trial initiation expected 2021 Primary endpoint: PFS vs R-CHOP
PoC; r/r B-cell malignancies + parsaclisib Final protocol in preparation
2
Other Other + lenalidomide + rituximab (R ) r/rNHL Follicular lymphoma (~500 pts) Trial initiation expected 2021 Primary endpoint: PFS vs R2
80 Dr. Jean-Paul Kress, M.D.
Chief Executive Officer, MorphoSys
81 Potential to transform the treatment U.S. peak sales potential for r/r DLBCL: US$ 500 – 750 million of patients with r/r DLBCL EU decision expected in H2 2021; additional global territories planned
Opportunity to improve cure rates Global pivotal trial ready to start in early 2021 in first-line DLBCL
Expanding global development into Global pivotal trial in r/r follicular lymphoma in preparation other B-cell malignancies Multiple additional opportunities
We are committed to unlocking Other NHLs (FL, MZL, MCL, CLL) the full potential of tafasitamab 1st line DLBCL
EMA decision r/r DLBCL FDA approval r/r DLBCL 82 Q&A Session
MorphoSys Incyte Jean-Paul Kress, CEO Hervé Hoppenot, Chairman & CEO Malte Peters, Chief R&D Officer Steven Stein, Chief Medical Officer Roland Wandeler, COO Barry Flannelly, GM North America Jens Holstein, CFO Christiana Stamoulis, CFO
83 Thank You
Monjuvi® is a trademark of the MorphoSys Group 84